Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

Shandong University

Status: Unknown

Conditions: Colonoscopy; Bowel Preparation

Treatments: Drug: 4L Polyethylene Glycol (PEG); Drug: 2L Polyethylene Glycol (PEG)

Study type: Interventional

Funder types: Other

Identifiers

NCT03765216

2018SDU-QILU-09

Details and patient eligibility

About

About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Full description

Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients aged 18 or older
• patients undergoing colonoscopy

Exclusion criteria

• patients with a history of colorectal surgery
• patients with severe colonic stricture or obstructing tumor
• patients with dysphagia
• patients with compromised swallowing reflex or mental status
• patients with significant gastroparesis or gastric outlet obstruction
• patients with known or suspected bowel obstruction or perforation
• patients with severe chronic renal failure (creatinine clearance<30 ml/min)
• patients with severe chronic renal failure (creatinine clearance<30 ml/min)
• patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)
• patients with inflammatory bowel disease or megacolon
• patients with dehydration
• patients with dehydration
• patients with pregnancy or lactation
• patients hemodynamically unstable
• patients unable to give informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 2 patient groups

Group A: standard group

Active Comparator group

Description:

Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.

Treatment:

Drug: 2L Polyethylene Glycol (PEG)

Group B: tailored group

Experimental group

Description:

Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage). Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.

Treatment:

Drug: 4L Polyethylene Glycol (PEG)

Drug: 2L Polyethylene Glycol (PEG)